Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-25 @ 2:07 AM
NCT ID:
NCT05308160
Eligibility Criteria:
Inclusion criteria
For inclusion in the study patients should fulfil the following criteria:
1. Provision of informed consent prior to the time of registration.
2. Aged 20-74 years male or female who are diagnosed with NAFLD and FibroScan shows CAP score ≥ 252 dB/m (≥Steatosis grade 2).
3.30 or more mL/min/1.73 m2 of estimated glomerular filtration rate 4.Female subjects must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception for the duration of the study (from the time they sign consent) and for 1 month after the last dose of IP to prevent pregnancy. In addition, oral contraceptives, approved contraceptive implant, long-term injectable contraception, intrauterine device, or tubal ligation are allowed. Oral contraception alone is not acceptable; additional barrier methods in conjunction with spermicide must be used.
5.Subjects who are blood donors should not donate blood during the study and for 1 month following their last dose of IP.
Exclusion criteria
Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
1. Viral hepatitis or other types of liver disorder (e.g. drug-induced or autoimmune hepatitis).
2. Alcohol consumption above recommended limits (male: more than 30g/ day; female: more than 20g/day converting to ethanol).
3. Serious liver dysfunction (Child-Pugh B or C).
4. History of any other malignancy within 1 years (with the exception of successfully treated non-melanoma skin cancers).
5. Patients with a known hypersensitivity to investigator product (IP).
6. Participation in another clinical trial within the previous 30 days or involvement in the planning and/or conduct of the study.
7. Previous enrolment or randomisation in the present study.
8. Active gallbladder diseases
9. For women is currently pregnant (confirmed with positive pregnancy test) or breast feeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
74 Years
Study:
NCT05308160
Study Brief:
Protocol Section:
NCT05308160